Defective Drug and Medical Device Blog

Shamrock Medical Solutions Mislabels Drugs

21April
2013

The Food and Drug Administration (FDA) last month advised healthcare providers to remove all products from a drug supplier due to improper labeling.

The FDA warned healthcare providers in April that drugs distributed by Shamrock Medical Solutions may be mislabeled and therefore should not be administered to patients. In its warning letter, the FDA wrote, “”This notice covers all drugs and dosage forms distributed by Shamrock including tablets, vials, ophthalmic and otic solutions and patches.”

Shamrock Medical Solutions out of Lewis Center, Ohio, is the leading provider of pharmaceutical unit dose repackaging services to the health care industry, and provides, according to the company’s webpage, over two hundred hospitals, pharmacies and medical centers across the country repackaged and relabeled drugs.

Although the company’s online site reports it repackages all drugs following USP and FDA guidelines and follows current Good Manufacturing Practices, the company has been warned in the past, once in 2010 and again in 2012, by the FDA for violations linked to the mislabeling of pharmaceutical drugs and is currently under fire for the same violations.

In its latest inspection, the FDA found that Shamrock had been distributing drugs with incorrect labels, labels that included: a different drug than what was included in the container; a drug with the wrong dose strength; and a drug not identified as extended release. These mislabeled drugs, of course, pose serious risks to patients.

“Patients may receive a drug that causes harm resulting in unintended effects. The potential risks include overdose, dangerous drug interactions, and unnecessary exposure to toxicity and side effects. Most importantly, patients would not receive the therapeutic benefits from the drug they need to take. In addition, patients may experience the side effects of a drug they do not need,” the FDA said.

Posted in Uncategorized |

The number of lawsuits leveled against Pfizer continues to rise

15April
2013

A lawsuit has been filed against the popular antidepressant manufacturer Pfizer claiming that use of the drug Zoloft during pregnancy led to serious birth defects in a woman’s unborn child. The woman who filed the lawsuit claims that her child will suffer from severe Zoloft side effects for the rest of his life.

This is just one of many lawsuits leveled against the pharmaceutical giant. As of April 2013 there have been dozens of other lawsuits filed by an SSRI birth defects lawyer on behalf of injured patients. The cases have been filed under multidistrict litigation, which standardizes pre-trial proceedings to avoid duplicate discovery and conflicting rulings

Zoloft has been linked to some serious birth defects including heart malformations, limb abnormalities, and gastrointestinal issues. Some of the children born with these defects require immediate surgery after birth. Some children have even died as a result of these birth defects. As of April 2013, there have been over 250 parents who have file lawsuits against Pfizer claiming that the company did not give adequate warning about the risk of using the drug during pregnancy.

In the most recent Zoloft lawsuit, the mother of the plaintiff alleges that she took the drug throughout her entire pregnancy, according to her physician’s prescription. After her son was born, he was diagnosed with a congenital heart disorder, a heart murmur, and congestive heart failure among a host of other health issues with the circulatory system.

The plaintiff also claims that the defects have also taken an emotional and physical toll on the mother’s body. The plaintiff is seeking punitive damages and treble compensation from the pharmaceutical powerhouse.

Legal experts expect that Pfizer will argue that it is a physician’s duty to warn patients about the dangers of using an antidepressant throughout a pregnancy.

Posted in Uncategorized |

Yaz Manufacturer Agrees to Settle Lawsuits

14April
2013

Two oral contraceptives that have recently been in the news are the contraceptives Yaz and Yasmin. Just last year, after numerous lawsuits, the Food and Drug Administration (FDA) ordered the company to place a stronger warning label on these products warning users of the increased risk of blood clots.

Bayer AG, the manufacturer of Yaz and Yasmin, has also been hit with a rash of lawsuits filed by plaintiffs who claim the use of these contraceptives have resulted in gall bladder injuries. These lawsuits claim Bayer knew of the health risks both Yaz and Yasmin posed, but failed to warn users.

In March, Bayer agreed to settle these lawsuits by agreeing to pay up to $24 million to those claiming gallbladder injuries from using Yaz or Yasmin. Bayer will pay $2,000 to those plaintiffs who suffered gall bladder injuries and $3,000 to those users who underwent surgery to remove their gall bladders.

After agreeing to the settlement, Bayer issued a statement saying the company does not believe that Yaz and Yasmin increase the risk of gall bladder injury when compared to other oral contraceptives.  However, in an emailed statement, a company spokesperson wrote that Bayer agreed to the settlement, which does not admit liability, “in order to avoid protracted and expensive litigation and to resolve the vast majority of pending gall bladder claims.”

If you have suffered injury due to the manufacturer’s improper warnings of a prescription drug, contact an experienced drug injury lawyer to discuss your medical and legal concerns.

Posted in Lawsuits, Side Effects |

Elderly Patients Likelier to Receive Dangerous Drugs

31March
2013

Seniors are likelier to get prescribed risky drugs, especially those living in Southern states according to a recent study at Brown University. Nearly one in five Southern seniors on Medicare has been prescribed potentially harmful drugs which have been advised against for people over 65.

As for the geographical differences, there was a 12 percent higher likelihood that an elderly person would get dangerous drugs in the South as opposed to places like New England. Factors like economic status, education, and quality of care are likely the cause of these regional differences.

The National Committee for Quality Assurance  created a list of over one hundred drugs which should be avoided by the elderly which includes things like benzodiazepines, and other anti-anxiety medications. Valium and similar others are not as easily metabolized in the elderly, so it stays in their system for a prolonged period of time. Muscle relaxers and diabetes medications can also have the same effect of staying in an older person’s system  too long to where it could become a serious danger.

Albany, Georgia had the highest amount of risky drugs prescribed, with nearly 40% of seniors on potentially harmful drugs. Alexandria, Louisiana was the city with the second highest concentration of dangerous prescriptions to the elderly.

Another widespread problem deals with polypharmacy, commonly known as using multiple medications. On average, a person over 65 is on about about four different prescription drugs, which can potentially lead to drug interactions. It is speculated that one third of hospital admissions is from are rooted in polypharmacy.

If you or a loved one has suffered from bad drugs or adverse drug interactions, make sure to contact an experienced drug attorney right away.

Posted in Side Effects |

High-Potency Cholesterol Drugs Linked to Kidney Injury

29March
2013

The use of highly potent cholesterol lowering drugs called statins have been linked to an increase in a person’s risk of developing kidney failure, a new study suggests. The research suggests that high potency versions of statin pills as opposed to low-potency pills are linked to slight elevated rates of kidney injury.

The study, which was conducted in different institutions and labs across Canada, estimates that for every 1,700 people who use high dose statins for a period of four-months, you would expect to see one person hospitalized.

While this number may seem insignificant the fact that there is widespread use of these statins can be cause for concern. According to the research “tens of millions” of North Americans are currently using these drugs so even side effects that are relatively uncommon are important to keep under control.

The research was conducted by the Canadian Network for Observational Drug Effect Studies, which is funded by Health Canada. The study was published in the medical journal BMJ. The data for the study was pulled from databases from seven Canadian provinces as well as from Britain and the United States. The study encompassed people aged 40 and older who had started taking statins between 1997 and 2008.

About 1/3 of the over 2 million people included in the study were administered the high-potency statins. High potency statins are defined as 10 milligrams or more of the active ingredient rosuvastatin, or as it is known commercially Crestor, 20 mg atorvastatin, which is sold as Lipitor, or 40 mg of simvastatin which is sold in pharmacies as Zocor.

Health Canada urges anybody who is currently taking a high-dose of statins to consult their physician to see if they may need to change their drug regimen.

Posted in Side Effects |

Diabetic Medication Linked to Pancreatic Cancer

20March
2013

Occasionally the dangers associated with taking a drug far outweigh the ailment that initially called for it to be prescribed. Drug-makers Merck, Bristol-Myers Squibb and Novo Nordisk, major manufacturers of diabetes drugs, are now being scrutinized for their reported link to pancreatic cancer.

The FDA is now launching an investigation into the side effects these drugs produce. The agency has already received a high number of reports indicating that users of these specialized drugs developed pancreatic cancer, devastating consequences for those simply trying to maintain quality of life amidst diabetes.

The problem with many bad drugs is the side effects are not readily apparent. Regardless of a company advertising the consequences or not, the harsh penalties associated with these drugs sometimes aren’t displayed for years. Trying to prevent the fatal consequences is a delicate process that requires fast legal proceedings and community awareness.

The FDA, deeming the diabetic drug complaints have reached a critical level, will now be investigating the unpublished findings from these major manufacturers. The FDA investigation will likely take a significant length of time, but the outcome could result a hefty bill to the manufacturers for significant damages stemming from a large list of complaints.

Posted in Side Effects |

Federal Regulators Urge Supreme Court to Change Legislation Regarding Generic Drugs

17March
2013

In Washington there has been an increase in urgency regarding large drug corporations paying off their competitors to delay generic drugs from being released. President Obama, the American Medical Association, and other consumer groups stressed the importance of lowering costs for those who can barely afford their prescriptions to the Supreme Court.

The large drug manufacturers argue that they need more money to replace the funds which go towards the research and development of new drugs and patents. These pay-for-delay deals happen when generic drug companies claim that the patent on a drug is flawed or invalid so they may formulate a cheaper version. The Food and Drug Administration (FDA) often gives these large pharmaceutical companies 20-year monopolies, which the generic companies try to get their cheaper version on the market before the patent expires.

The large companies are not too thrilled about these sorts of lawsuits, as years of litigation are likely to ensue which often results in a compromise. The generic suppliers usually release their drug in a few years, allowing the big pharma company to receive all of the revenue for the drug. The compromise usually involves a hefty settlement to the generic drug company.

The US is now trying to get these generic drugs faster, even though both companies seem to benefit from the pay-to-delay, the American people are the ones in consideration.  The FTC claims that this new legislation could make the drug industry less competitive but it could mean more savings for the government. In 2011, US tax payers and patients saved $193 billion dollars through the use of generic drugs.

Posted in Drug Companies |

Navy Launches PSA Against Bath Salts

6March
2013

The US Navy has now joined the war on bath salts, launching their own PSA against the synthetic drug growing in popularity. The drug remains easily accessible in many areas of the country. Many packages of bath salts include the warning, ‘not for human consumption’, as a simple method of skirting the law.

Bath salts, named for its resemblance to legal bathing products like epsom salts, operates quite differently. The drug generally contains substituted cathinones, providing a similar effect as amphetamine and cocaine.

Following a string of high profile national incidents, the US Navy has issued a warning to potential sailors enlisting for service, cautioning them of the dangerous hallucinatory affects associated with bath salts.

The video depicts an active service member snorting a line of bath salts with disastrous consequences, a shocking display that’s successfully turned a lot of heads. The hellish commercial displays an act of physical abuse and ends with the sailor being forcibly restrained to a gurney.

As the drug is relatively new to the market, there’s little in the way of research of the effect is has over the body. Many believe chronic bath salts abuse can actually cause disruptive and permanent changes within the brain of the user.

Now a nationally televised Navy PSA seems to creating greater awareness.

Posted in Side Effects |

Search Engines Offer Key Insights into Drug Side Effects and Interactions

3March
2013

The internet continues to play a key role in almost every aspect of our lives, now it has even began helping in the detection of drug side effects before the FDA. From analyzing the queries of popular search engines, it can potentially help reveal medical risks that were undetected in clinical trials.

In 2010, researchers looked into queries relating to Paroxentine, an antidepressant and pravastatin, a cholesterol lowering drug and concluded that taking the two together resulted in higher blood sugar. People who were googling “Paroxentine and Pravastatin” helped them determine that these two had some sort of correlation. One in ten of the people who used a search engine also searched for hypoglycemia as well.  Researchers then found that in 81% of time, people were likely to become hypoglycemic while taking the drug combination based off the searches. These data mining techniques are similar to the ways that Google compiles its flu trends, which has been a useful warning to the public.

Some scientists are now pressing Google and other resources, like Bing and Yahoo, to monitor these kinds of searches then send them to the FDA for further investigation. Although bio-medical professionals are unsure of how much these observations will help, they do want to explore the usefulness of data mining.

Typically, the FDA receives this kind of drug side-effect information through the Adverse Event Reporting System, which only contains reports from doctors, not patients. The reach of this of data is limited, because all of the symptoms which are reported are that of the doctor’s observations. If you have been the victim of a drug’s side effect, make sure to contact an attorney who can hold the right people accountable, and get you the compensation you deserve.

Posted in Side Effects |

Bayer Fights Against Federal Multi-District Litigation Consolidation

24February
2013

Although Bayer petitioned the New Jersey courts to consolidate Mirena IUD cases, Bayer is now opposing consolidation in the federal courts.

This latest battle began when plaintiff’s counsel filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the federal cases in the Northern District of Ohio. However, soon after this Bayer argued that MDL will prejudice the company. Bayer contends that one lawsuit is already scheduled for trial in May of this year. Bayer says that it has spent significant resources defending the case. If the JPML orders consolidation in federal court Bayer believes that it will be forced to start over and duplicate the time consuming process of discovery.

Further, Bayer argues that an MDL will encourage plaintiffs to file meritless claims. Additionally, the company says that the cases currently filed do not meet the commonality requirement because there are no injuries in common in every of the 8 pending federal cases. The most common injury, uterine perforation, has only been plead in 6 of the 8 cases. Further, Bayer argues that it has warned of the risk of uterine perforation and that there will be no need for pervasive discovery on the issue.

Although Bayer had originally requested consolidation in New Jersey courts in August, the corporation says that procedural irregularities in New Jersey made adjudication of the claims in separate state districts impossible. With the federal cases, on the other hand, Bayer argues that each federal court could just as easily handle the claims as any other federal court.

The plaintiffs took issue with Bayer’s assertions. The plaintiffs argue that Mirena labels did not actually warn against uterine perforation. Plaintiffs also believe that once consolidated hundreds of similar lawsuits will be filed.

Posted in Multidistrict Litigation |